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Scrum in a validated environment

One thing has become crystal clear the last couple of days:Using Scrum in a validated (Pharmaceutical) environment requires a somewhat different approach.

In a validated environment a number of documents, that are normally not required in Scrum, have to be delivered. These documents, Functional specifications, Risk Impact analysis, … are artifacts from the classical approaches. The solution we came up with is to have a task in each single sprint that states updating these documents. This way, after every Sprint, the documents will be updated, and thus the documents will be finished after the last sprint, ready for acceptance by the Business.

However, this is not the biggest challenge in a validated environment. The people working with these projects are used to doing everything by the rule. Using Scrum, we bend the rules a little bit. For example, we don’t have the Functional Specifications signed off by the business prior to the development phase. This makes some people very nervous. Every day I realize more that this project will be more about coaching the team towards Scrum, than focusing on my task as Scrum Master.

We have started writing User Stories, this makes the analysts feel uncomfortable. They want to have everything defined up front, but that is not what User Stories do. They will have to wait until the first Sprint Planning meeting to get the details. This first meeting will be on the 1st of October …

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2 thoughts on “Scrum in a validated environment”

Hi Peter,I think you've hit the nail on the head when you say its going to be more about educating the team towards Scrum.I've been working on a Scrum based project for the last 14 months, for a large UK based company. I love Scrum as its win-win for everyone involved (but not always suited to every project). In these early days you have to hold your nerve and try to resist the pressure to run the project in a traditional waterfall manner. After the first few Sprints the business will really see the benefits, as they see real progress being made on a regular basis. In my opinion the business/end users just love the process as to them it hands back some control – it's usually IT personnel that put up the most resistance, as they cant accept that something so simple can possibly work without reams of documentation, convulate processes, and endless meetings!Good luck,Paul Brookes